- Merck & Co. (Rahway, NJ)
- …programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination ... teams.Proven track record of applying analytical skills in product design, development, and validation .-Proven ability to lead team members of diverse skill sets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Required Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - Preferred Experience10+ years of experience in GxP-regulated ... Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization.… more
- BioAgilytix (Durham, NC)
- …build the rules, processes, and cloud pipelines that keep lab and business information accurate, secure, and easy to find. That means hands-on work designing Azure ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations...qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… more
- Novo Nordisk Inc. (Durham, NC)
- …Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and ... practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... validation , with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled verbal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor ... Training, QC, EM, Operations Technical Support, Facilities and Engineering, Validation .Requirements B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field. Trade /… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (San Francisco, CA)
- …seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build ... decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be responsible for… more
- L3Harris Technologies (Bountiful, UT)
- …air, land, sea and cyber domains in the interest of national security. Job Title: Lead , Systems Engineer Job Code: 24436 Job Location: USA-UT-Salt Lake City Job ... and have every other Friday off Job Description: The Lead , Network Systems Engineer will be responsible...process flow down. They will understand System Verification and Validation , and following Systems Engineering processes. The… more
- Woven by Toyota (Palo Alto, CA)
- …Developer Efficiency team is central to the development of Advanced Driver Assistance Systems (ADAS) at Woven by Toyota. We build the frontend and backend frameworks ... that power ADAS software validation workflows using data from real-world driving, simulation, and...We are looking for a Senior Engineering Manager to lead a team focused on delivering modular, scalable backend… more
- Resideo (Lehi, UT)
- Job Description We are seeking a Senior Product Validation Engineer to lead the development of automated testing for our line of smart home devices and lighting ... in IoT or smart home devices. Experience using AI tools for Product Validation and testing Experience validating embedded systems , wireless protocols. Experience… more